Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously.
Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility.
Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports.
Write reports summarizing results and statistics for all equipment, products, or process validation projects.
Work with end users and process owners to collect data to support protocol requirements, analyze data collected, and create validation reports.
Coordinate with end users and process owners to lead the development of validation protocols.
Learn and understand the applicable technology and engage in technical discussions.
Identify areas and opportunities to improve manufacturing facilities, processes, and equipment.
Provide consultation to other departments performing validation activities.
Ensure the validation program meets FDA and Site-Specific requirements.
Requirements
Bachelor's degree in engineering or science and 2-5 years of related experience is required.
2+ years' experience in the biotech, pharmaceutical, or medical device industry in developing and deploying Quality Systems, process controls, and continuous improvement methods.
Must have validation experience of GMP IT or Automation Systems, (2+ years preferred).
Test protocol or test script authoring.
Test execution.
Documentation of failures or non-conformances.
Resolution of failures or non-conformances.
Familiarity with electronic validation/QMS systems such as Veeva, Master Control, Valgenesis, Service Now, or KNEET.
Knowledge and working application of FDA, and CGMP requirements.
Intermediate knowledge and working application of Validation Principles and guidelines and industry practice.
Knowledge in Calibration and Environmental Monitoring Programs.
Knowledge and working application of standard operating procedures.
Ability to multi-task and methodically manage projects.
Demonstrated ability to accomplish goals while working across departments is required.
Demonstrated strong analytical problem-solving, team, and communications/interpersonal skills.
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